NCT02434003 Prospective Multicenter Evaluation of a New Predictive Model for the Progression of Adolescent Idiopathic Scoliosis
| NCT ID | NCT02434003 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Justine's Hospital |
| Condition | Scoliosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2014-05 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,200 participants in total. It began in 2014-05 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Scoliosis is a three-dimensional deformity affecting the orientation and position of the spine. Locally, the shape of the vertebra is also affected. The most common form is adolescent idiopathic scoliosis (AIS) with a prevalence of 1-3% affecting primarily young adolescent females. AIS can either be treated using a brace and in some cases necessitate surgical correction to prevent progressive deformity. Risk factors for progression include female gender, curve magnitude and location, skeletal maturity and growth velocity. However, these risk factors have been shown to be inconsistent in predicting curve progression. Over the past 6 years, the investigators have developed a predictive model of the final Cobb angle in AIS based on 3D spinal parameters. This analysis was based on a prospective cohort of 195 patients that were enrolled upon their initial visit and followed until maturity. This predictive model has a determination coefficient of 0.702. The proposed new study aims at refining and testing the external validity of this model in a larger cohort. The next step towards using the new model in the clinical setting is to redesign the model and to externally validate the model by measuring the agreement between the new method and the traditional Cobb angle at maturity in a larger multicenter study. The objective of this study is to characterize the risk of scoliosis progression based on local three-dimensional vertebral and pelvic measurements present on initial evaluation. Three-dimensional reconstructions will be derived from stereo-radiographs acquired with a new biplanar low-dose radiographic system installed in all 8 clinical sites (EOS system, EOS-Imaging, Paris). These calibrated radiographs will then be used to reconstruct the vertebrae and intervertebral disks at each level as well as the geometry of the pelvis. A series of local and regional parameters will then be calculated from these 3D reconstructions. Correlation analysis will help determine if intervertebral disk wedging, vertebral wedging, transverse plane rotation or pelvic geometry can be used as early predictors of curve progression in AIS. Identifying a new 3D measure of scoliosis associated with rapid curve progression could help predict which curves need early treatment to prevent further progression. The ultimate goal of this research project will be to validate this new predictive model and finally transfer this new predictive tool in the hands of clinicians treating AIS.
Eligibility Criteria
Inclusion Criteria: * Idiopathic Scoliosis (as diagnosed by the surgeon) * Patients above 10 year old at the time of recruitment * Spina bifida occulta with no neurological signs and otherwise normal * Curves ranging between 11º and 40º of Cobb angle measurement and * Risser 0 or 1, as measured on a standing postero-anterior digital radiograph of the spine. * All single thoracic, thoraco-lumbar, lumbar, double major and triple major curves will be included in the study. Exclusion Criteria: * Previous thoracic, pelvis or spine surgery as they may be co-factors in scoliosis initiation, * Congenital scoliosis, * MRI abnormalities (including \> 4mm of Syrinx and/or Chiari malformation) * Syndromic scoliosis (associated with Marfan's or other genetic syndromes), * Neuromuscular scoliosis, * Developmental delay * Spinal asymmetry * Symptomatic spondylolisthesis * Leg length discrepancy longer than 1 cm. * Unable or unwilling to firmly commit to returning for required follow-up visits
Contact & Investigator
Stefan Parent, MD, PhD
✉ stefan.parent@umontreal.caStefan Parent, MD, PhD
PRINCIPAL INVESTIGATOR
St. Justine's Hospital
Frequently Asked Questions
Who can join the NCT02434003 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 15 Years, studying Scoliosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02434003 currently recruiting?
Yes, NCT02434003 is actively recruiting participants. Contact the research team at stefan.parent@umontreal.ca for enrollment information.
Where is the NCT02434003 trial being conducted?
This trial is being conducted at San Diego, United States, Wilmington, United States, Miami, United States, Minneota, United States and 5 additional locations.
Who is sponsoring the NCT02434003 clinical trial?
NCT02434003 is sponsored by St. Justine's Hospital. The principal investigator is Stefan Parent, MD, PhD at St. Justine's Hospital. The trial plans to enroll 1,200 participants.